Inpeco S.A. recalls Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP),…
Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either…
Read the official notice →- Date
- 2023-05-10
- Country
- United States
- Brand
- Inpeco
- Product
- Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP),…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of ARGENTINA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Inpeco recalls
- 2025-12-03
USInpeco S.A. recalls FlexLab (FLX); Version: FLX-217-40;
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer…
FDA · DeviceInpeco S.A.US Domestic: MI. OUS International: Australia, Finland, France, Germany,…Official notice →- 2025-10-15
- US
Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the…
- US
Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the…
- 2023-12-27
- US
Inpeco S.A. recalls Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate…
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
FDA · DeviceInpeco S.A.Worldwide - US Nationwide distribution in the state of MA and the countries of…Official notice → - 2021-10-20
- US
Inpeco S.A. recalls FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient…
FDA · DeviceInpeco S.A.Domestic distribution nationwide . Foreign distribution worldwide.Official notice →
Other drugs & medical recalls in the United States
- 2023-05-17
- US
The Harvard Drug Group recalls Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo…
Product mixup: one foreign tablet found in product.
- US
Apotex Corp. recalls Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL…
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
- US
Camber Pharmaceuticals Inc. recalls Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,…
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
- 2023-05-10
- US
DeVilbiss Healthcare LLC recalls DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil…Official notice → - US
Linkbio Corp. recalls LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal…
FDA · DeviceLinkbio Corp.NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland,…Official notice →